AnesthesiaNCT02124499
Genetic Variants and Perioperative Morbidity and Mortality
An observational study of Anesthesia and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Analgesia, Surgical Procedure, Operative
- How many people
- 20,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective surgery
Who may be able to join
- 18 years and older
- Written informed consent
- Scheduled surgery
Who cannot join
- No informed consent
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010
Frank Stüber, Professor MD, 041-316322483, frank.stueber@insel.ch
Anneliese Hoffmann, PhD, 0041-316328872, lan.zhang@unibe.ch
About this study
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.
Read the detailed description
Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome.
In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery.
Objective
The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants.
Methods
Prospective association study performed in two independent patient cohorts.
- Conditions
- Anesthesia, Analgesia, Surgical Procedure, Operative
- Keywords
- anesthesia recovery period, postoperative complications, pain, pain measurement, postoperative nausea and vomiting, quality of life, genetic association study
- Medical subject headings
- Agnosia, Postoperative Complications, Pain, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing elective surgery with anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting (PONV)
Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV
Measured: Up to 48 hours after surgery
Secondary outcomes (5)
Pain related impairment after surgery
Measured by the International Pain Outcomes Questionnaire
Measured: up to 2 days after surgery
Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery
Measured by the Brief Pain Inventory (BPI)
Measured: up to one year after surgery
Cardio-vascular events after surgery
Measured by a score for major adverse cardiac events (MACE)
Measured: Up to 30 days after surgery
Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery
Measured by the Brief Pain Inventory (BPI)
Measured: up to one year after surgery
What influences pain related impairment after bariatric surgery
Measurement of patient reported outcome by the BPI (Brief Pain Inventory).
Measured: up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start2 Jan 2011
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Stüber, Prof. MD, Study chair, Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of BernUlrike M Stamer, MD, Principal investigator, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124499
- Sponsor's protocol ID
- 041/09
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2014
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants and Perioperative Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT02124499
- Acronym / sponsor ID
- 041/09
- Conditions
- Anesthesia, Analgesia, Surgical Procedure, Operative
- Keywords
- anesthesia recovery period, postoperative complications, pain, pain measurement, postoperative nausea and vomiting, quality of life, genetic association study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Jan 2011 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.
Detailed description
Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome.
In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery.
Objective
The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants.
Methods
Prospective association study performed in two independent patient cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Patients undergoing elective surgery with anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery
Key inclusion criteria (3 listed)
- 18 years and older
- Written informed consent
- Scheduled surgery
Key exclusion criteria (2 listed)
- No informed consent
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative nausea and vomiting (PONV)
Time frame: Up to 48 hours after surgery
Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV
5 secondary outcomes
Pain related impairment after surgery
Time frame: up to 2 days after surgery
Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery
Time frame: up to one year after surgery
Cardio-vascular events after surgery
Time frame: Up to 30 days after surgery
Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery
Time frame: up to one year after surgery
What influences pain related impairment after bariatric surgery
Time frame: up to 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Stüber, Prof. MD study chair
Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern
Ulrike M Stamer, MD principal investigator
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrike M Stamer, Prof. MD (0041-316329995, ulrike.stamer@dbmr.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (PONV) (time frame: Up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.